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Sentinel Lymph Node in Early-Stage Endometrium Cancer

NCT06163963RecruitingNAINTERVENTIONAL

Summary

The aim of this prospective study is to investigate whether the detection rate of sentinel lymph node (SLN) with double tracer injected at two different sites may be increased compared to the standard use of a single tracer with single site (cervix) injection in early-stage endometrial cancer.

Key Facts

Lead Sponsor

Istanbul University

Enrollment

100

Start Date

2023-07-01

Completion Date

2025-11-01

Study Type

INTERVENTIONAL

Official Title

Sentinel Lymph Node Mapping with Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer

Interventions

Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancercharcoal injection to uterus to map sentinel lymph nodes

Conditions

Sentinel Lymph NodeEndometrial Cancer

Eligibility

Age Range

18 Years – 90 Years

Sex

FEMALE

Inclusion Criteria:

1. Must have preoperative histologic diagnosis of endometrial carcinoma
2. Must be in early stage ( stage1 and 2) endometrial carcinoma radiologically and clinically
3. Must have written informed consent

Exclusion Criteria:

1. Possible allergic reaction to commonly used drugs
2. Medical or surgical contraindications for comphrensive staging
3. Preoperative or intraoperative findings of advanced endometrial cancer

Outcome Measures

Primary Outcomes

Detection rate of sentinel lymph nodes with double tracer in early stage endometrial carcinoma

Detection rates of sentinel lymph nodes for both tracers in every pelvic and paraaortic lymph node basin are the primary outcome of the study.Sentinel lymph node detection rates of each region (pelvic, obturator, inframesenteric para-aortic, supra-mesenteric - infrarenal para-aortic), bilaterality/ unilaterality and staining with single or double tracer will be discussed compared to literature data.

Time frame: From the day of surgery to final pathology report (2 weeks)

Locations

Istanbul University Medical Faculty Dept. of Obstet Gynecol, Division of Gynecologic Oncology, Istanbul, Turkey (Türkiye)

Linked Papers

2020-10-20

Adjuvant therapy for endometrial cancer in the era of molecular classification: radiotherapy, chemoradiation and novel targets for therapy

Endometrial cancer is primarily treated with surgery. Adjuvant treatment strategies for endometrial cancer, such as external beam pelvic radiotherapy, vaginal brachytherapy, chemotherapy, and combined chemotherapy and radiotherapy, have been studied in several randomized trials. Adjuvant treatment is currently based on the presence of clinico-pathological risk factors. Low-risk disease is adequately managed with surgery alone. In high-intermediate risk endometrial cancer, adjuvant vaginal brachytherapy is recommended to maximize local control, with only mild side effects and without impact on quality of life. For high-risk endometrial cancer, recent large randomized trials support the use of pelvic radiotherapy, especially in stage I-II endometrial cancer with risk factors. For women with serous cancers and those with stage III disease, chemoradiation increased both recurrence-free and overall survival, while GOG-258 showed similar recurrence-free survival compared with six cycles of chemotherapy alone, but with better pelvic and para-aortic nodal control with combined chemotherapy and radiotherapy. Recent molecular studies, most notably the work from The Cancer Genome Atlas (TCGA) project, have shown that four endometrial cancer molecular classes can be distinguished;

Endometrial cancer

Endometrial cancer is the most common gynaecological cancer in high income countries and its incidence is rising globally. Although an ageing population and fewer benign hysterectomies have contributed to this trend, the growing prevalence of obesity is the major underlying cause. Obesity poses challenges for diagnosis and treatment and more research is needed to offer primary prevention to high-risk women and to optimise endometrial cancer survivorship. Early presentation with postmenopausal bleeding ensures most endometrial cancers are cured by hysterectomy but those with advanced disease have a poor prognosis. Minimally invasive surgical staging and sentinel-lymph-node biopsy provides a low morbidity alternative to historical surgical management without compromising oncological outcomes. Adjuvant radiotherapy reduces loco-regional recurrence in intermediate-risk and high-risk cases. Advances in our understanding of the molecular biology of endometrial cancer have paved the way for targeted chemotherapeutic strategies, and clinical trials will establish their benefit in adjuvant, advanced, and recurrent disease settings in the coming years.

Linked Investigators

Anne Sophie V M van den Heerik

Nanda Horeweg

Assistant professor @ Department of Radiation Oncology - Leiden University Medical Center - the Netherlands. Clinical Epidemiologist. Methodological lead and contributions to clinical trials, such as PORTEC 4a, RAINBO platform trials and PROQEM, and international research consortia such as TransPORTEC and AIR-MEC.